Disposable Pen Needle With Re-Use Prevention Features

ABSTRACT

A needle assembly, comprising hub, a needle fixedly connected to said hub, an outer cover for removably receiving said hub and said needle, said outer cover covering a first end of said needle and an inner shield adapted to be connected to said hub for covering a second end of said hub.

FIELD OF THE INVENTION

This application is a continuation of U.S. patent application Ser. No.14/186,365 filed on Feb. 21, 2014, which is a continuation of U.S.patent application Ser. No. 13/138,306 filed on Oct. 10, 2011, now U.S.Pat. No. 8,764,706, which is a national stage of International PatentApplication No. PCT/US2010/00305, filed Feb. 4, 2010, which claims thebenefit under 35 U.S.C. §119(e) of U.S. Provisional Application Ser. No.61/150,671, filed Feb. 6, 2009. These applications are herebyincorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to a disposable pen needle withre-use prevention features. More particularly, the present inventionrelates to a disposable pen needle in which a cap of an outer cover hasa tab that is connectable to the cap to prevent reuse of the pen needle.The present invention also relates to a pen needle that is lockablewithin an outer cover to prevent reuse of the pen needle.

BACKGROUND OF THE INVENTION

Insulin and other injectable medications are commonly given with drugdelivery pens, whereby a disposable pen needle is attached to facilitatedrug container access and allow fluid egress from the container throughthe needle into the patient.

As technology and competition advance, driving the desire for shorter,thinner, less painful, and more efficacious injections, the design ofthe pen needle and parts thereof becomes more and more important.Designs need to proactively address ergonomically improving injectiontechnique, injection depth control and accuracy, the ability to besafely used and transported to disposal, and protection against misusewhile maintaining the ability to be economically manufactured on a massproduction scale.

Drug delivery devices, such as the exemplary drug delivery pen 100 shownin FIGS. 1 and 2, can be designed for subcutaneous, as well asintradermal, injections and typically comprise a dose knob/button 24, anouter sleeve 13, and a cap 21. The dose knob/button 24 allows a user toset the dosage of medication to be injected. The outer sleeve 13 isgripped by the user when injecting medication. The cap 21 is used by theuser to securely hold the drug delivery pen 100 in a shirt pocket, purseor other suitable location and provide cover/protection from accidentalneedle injury.

FIG. 2 is an exploded view of the drug delivery pen 100 of FIG. 1. Thedose knob/button 24 has a dual purpose and is used both to set thedosage of the medication to be injected and to inject the dosedmedicament via the leadscrew 7 and stopper 15 through the medicamentcartridge 12, which is attached to the drug delivery pen through a lowerhousing 17. In standard drug delivery pens, the dosing and deliverymechanisms are all found within the outer sleeve 13 and are notdescribed in greater detail here as they are understood by thoseknowledgeable of the prior art. The distal movement of the plunger orstopper 15 within the medicament cartridge 12 causes medication to beforced into the steel needle 11 of the hub 20. The medicament cartridge12 is sealed by septum 16, which is punctured by a septum penetratingneedle cannula 18 located within the hub 20. The hub 20 is preferablyscrewed onto the lower housing 17, although other attachment means canbe used, such as attaching to the cartridge. To protect a user, oranyone who handles the pen injection device 100, an outer cover 69,which attaches to the hub 20, covers the hub. An inner shield 59 coversthe patient needle 11 within the outer cover 69. The inner shield 59 canbe secured to the hub 20 to cover the patient needle by any suitablemeans, such as an interference fit or a snap fit. The outer cover 69 andthe inner shield 59 are removed prior to use. The cap 21 fits snuglyagainst outer sleeve 13 to allow a user to securely carry the drugdelivery pen 100.

The medicament cartridge 12 is typically a glass tube sealed at one endwith the septum 16 and sealed at the other end with the stopper 15. Theseptum 16 is pierceable by a septum penetrating cannula 18 in the hub20, but does not move with respect to the medicament cartridge 12. Thestopper 15 is axially displaceable within the medicament cartridge 12while maintaining a fluid tight seal.

An exploded perspective view of a pen needle 2 of an exemplary drugdelivery pen is shown in FIG. 3. The pen needle 2 includes the cover(outer shield) 69, an inner shield 59, a needle cannula 11, and a hub20. A proximal end 310 of the needle cannula 11 is inserted into acenter opening in the distal (patient) end 405 of the hub 20 until apredetermined length of the distal (patient) end 305 of the needlecannula 11 remains extended. The needle cannula 11 is secured by epoxyor adhesive in the distal end 405 of the hub 20 within the hubprotrusion 420.

To protect users from injury and the needle cannula 11 from beingdamaged, the inner shield 59 covers the exposed portion of the needlecannula 11. The open proximal end 210 of the inner shield 59 is placedover the exposed portion of the needle cannula 11. The open proximal end110 of the cover 69 envelops the inner shield 59, needle cannula 11, andhub 20.

The distal end 105 of the cover 69 is closed to prevent contaminationand damage to the inner components of pen needle 2, and to preventinjury to anyone who may handle it prior to use. The proximal end 410 ofthe hub 20 is typically covered by a sanitary paper or foil cover (notshown) glued on an end 110 of the cover 69. The drug delivery pen isthen ready for shipment to a user. When the user is ready to use thedrug delivery pen, the sanitary cover (not shown) is removed from thecover 69, the hub 20 is screwed onto a lower housing 17 of a standardpen 100 (FIGS. 1 and 2), and the cover 69 and shield 59 are separatelyremoved from the hub 20/cannula 11 subassembly by a pulling action. Thedistal end 205 of the inner shield 59 is closed to cover the distal end305 of the needle cannula 11 after the cover 69 is removed to protectthe user from an accidental needle stick. The inner shield 59 is thenremoved to access the needle cannula 11. Thus, two separate pullingactions are required to remove both the cover 69 and the shield 59.

Many existing replacement needle assemblies include an inner shield andouter cover. The outer cover typically has a sanitary paper or foil sealthat a user must remove to connect the pen needle to the cartridge ofthe pen assembly. However, the sanitary seal can be difficult to graspand remove from the pen needle. Furthermore, once the sanitary seal isremoved from the pen needle, nothing prevents a used pen needle that hasbeen removed from a pen cartridge from being reused. Moreover, withoutthe sanitary seal, nothing prevents a user from being accidentally stuckby the uncovered needle. Thus, a need exists for a pen needle that iseasy to use and prevents reuse.

Another existing problem with pen needles is that there is no means toeasily determine whether the pen needle has been previously used. Thus,a need exists for a pen needle that locks the pen needle in an outercover to prevent reuse. A need also exists for a pen needle that has acolor indicator to indicate that the pen needle has been previouslyused.

Existing drug delivery pens are disclosed in U.S. Patent ApplicationPublication Nos. 2006/0229562 to Marsh et al., published on Oct. 12,2006, and 2007/0149924 to R. Marsh, published on Jun. 28, 2007, theentire contents of both of which are hereby incorporated by reference.

Accordingly, a need exists for a disposable pen needle having an outercover including a cap having a tab that is connectable to the cap toprevent reuse of the pen needle and to provide an easy to use penneedle.

SUMMARY OF THE INVENTION

In accordance with an aspect of the present invention, a need exists fora pen needle that is lockable within the outer cover to prevent reuse.

In accordance with another aspect of the present invention, a cap of anouter cover of a pen needle has a tab that protrudes outwardly from theouter cover to provide a cap that is easily opened to provide access tothe pen needle.

In accordance with another aspect of the present invention, the tab issecurable to the cap to lock the cap to the outer cover, therebypreventing reuse of a used pen needle and preventing accidental needlesticks from the used pen needle.

In accordance with another aspect of the present invention, a needexists for a pen needle that has a color indicator to clearly indicatewhether the pen needle has been used.

The foregoing objects are basically attained by providing a pen needlefor a drug delivery device that includes a hub and a needle fixedlyconnected to the hub. An outer cover removably receives the hub and theneedle. A locking member locks the hub and the needle in the outercover.

Objects, advantages, and salient features of the invention will becomeapparent from the following detailed description, which, taken inconjunction with the annexed drawings, discloses exemplary embodimentsof the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above benefits and other advantages of the various embodiments ofthe present invention will be more apparent from the following detaileddescription of exemplary embodiments of the present invention and fromthe accompanying drawing figures, in which:

FIG. 1 is a perspective view of an assembled drug delivery pen;

FIG. 2 is an exploded perspective view of the drug delivery pen of FIG.1;

FIG. 3 is an exploded perspective view of a pen needle of the drugdelivery pen of FIGS. 1 and 2;

FIG. 4 is an elevational view of an outer cover for a pen needle havinga tab connected to the cap, and the cap being connected to the outercover according to an exemplary embodiment of the present invention;

FIG. 5 is an elevational view of the outer cover in which the cap isopened to provide access to the pen needle;

FIG. 6 is an elevational view of the outer cover in which the outercover is separated from the pen needle to connect the pen needle to acartridge;

FIG. 7 is an elevational view of the outer cover in which a used penneedle has been separated from the cartridge and is received by theouter cover;

FIG. 8 is an elevational view of the outer cover in which the cap isclosed and the tab is being moved to a locked position;

FIG. 9 is an elevational view of the outer cover in which the tab islocked to the cap of the outer cover;

FIG. 10 is a perspective view of the outer cover and cap of the penneedle of FIG. 4 with an unlocked tab;

FIG. 11 is a perspective view of the outer cover and cap of the penneedle of FIG. 9 with a locked tab;

FIG. 12 is an elevational view in cross section of an outer coveraccording to another exemplary embodiment of the present invention;

FIG. 13 is a perspective view of an inner shield according to anotherexemplary embodiment of the present invention;

FIG. 14 is a perspective view of a hub according to another exemplaryembodiment of the present invention;

FIG. 15 is an elevational view in partial cross section of an assembledpen needle assembly of FIGS. 12-14 in which the inner shield isconnected to the hub;

FIG. 16 is an elevational view in partial cross section of an assembledpen needle assembly of FIGS. 12-14 in which the hub is locked to theouter cover;

FIG. 17 is an elevational view in partial cross section of an assembledpen needle assembly of FIGS. 12-14 in which the hub is locked to theouter cover and the hub has a color indicator;

FIGS. 18 and 19 are perspective views of a threaded inner shieldaccording to another exemplary embodiment of the present invention;

FIG. 20 is a perspective view of an inner shield of FIG. 18 or 19threadably engaged with a needle hub to shield a non-patient end of aneedle;

FIG. 21 is a perspective view of an inner shield having a stepped baseaccording to another exemplary embodiment of the present invention;

FIG. 22 is a perspective view of a hub having flexible arms adapted toreceive the inner shield of FIG. 21; and

FIG. 23 is an elevational view in partial cross section of the innershield of FIG. 21 connected to the hub of FIG. 22 to shield anon-patient end of a needle.

Throughout the drawings, like reference numbers will be understood torefer to like parts, components and structures.

Detailed Description of the Exemplary Embodiments

The following description and details of exemplary embodiments of thepresent invention, while generally disclosed in a typical drug deliverypen, as shown in FIGS. 1-3, could more broadly apply to a needle and hubassembly for use in conjunction with, or incorporated onto, otherinjection devices such as syringes, autoinjectors and infusion devices.

In an exemplary embodiment of the present invention shown in FIGS. 4-9,an outer cover 501 is connected to a hub 511 of a pen needle 521, suchas by a friction fit. The hub 511 has a needle 502 rigidly fixedthereto. A rigid plastic cap 503 is connected to the outer cover 501,such as by a living hinge 531. Preferably, the living hinge is formedduring molding of the outer cover 501. Alternatively, the cap 503 may besnap fitted to the outer cover 501. The cap 503 has an integral,outwardly extending tab 505 to allow the user to grasp the tab easily,thereby facilitating opening of the cap by a user.

The outer cover 501 has a substantially cylindrical body 507. The cap503 is connected to a first end of the body 507. An inwardly taperingbody portion 508 is connected to a second end of the body 507. Aprojection 509 extends outwardly from the tapered body portion 507 in adirection away from the cap 503. The projection 509 is adapted toreceive the needle 502 of the hub 511.

The cap 503 is preferably substantially circular, as shown in FIGS. 10and 11. However, the tab 505 may be any suitable shape. The tab 505 isshaped to allow the user to grasp or engage the tab 505 more easily tofacilitate opening and closing the cap 503. The cap 503 has a recess 533and the outer cover 501 has a recess 535 through which the tab 505extends, as shown in FIG. 10, prior to the tab being locked to the cap.

To lock the tab 505 to the cap 503, the tab is moved into the recess 533in the cap, thereby preventing the cap from being removed from the outercover 501. The tab 505 may be connected to the cap in any suitablemanner that allows the tab to be disposed in the cap recess 533. The tabmay be initially rigidly attached to the cap 503 by a weakened line. Thetab 505 is pushed upwardly by a user's finger to open the cap, as shownin FIG. 5. After the needle 502 is used and disposed in the outer cover501, the cap 503 is held closed while the tab 505 is pivoted, or broken,at the line and secured within the recess 533, as shown in FIGS. 8 and9. The tab 505 may be slightly larger than the cap recess 533 such thatdisposing the tab 505 in the recess 533 causes the cap 503 to expand tomore securely secure the cap to the outer cover 501.

As shown in FIG. 4, prior to use of the pen needle 521, the cap 503 issealed to the outer cover 501, thereby covering both ends of the needle502 to maintain sterility and prevent an accidental needle stick. Whenthe pen needle 521 is ready to be used, the cap 503 is opened to provideaccess to the hub 511 and needle 502, as shown in FIG. 5. The hub 511 isthen connected to a lower housing 17 of a pen (FIG. 2) and the outercover 501 is separated from the hub 511 and needle 502, as shown in FIG.6. Once the needle 502 has been used, the hub 511 and needle 502 areseparated from the lower housing 17 of the drug delivery device 100(FIG. 1), reinserted in the outer cover 501 and the cap 503 is closed,as shown in FIG. 7. The cap 503 preferably creates an interference fitwith the outer cover 501 to secure the cap to the outer cover. The tab505 is then moved to a locked position, as shown in FIG. 8. Once the tab505 is locked to the cap 503, as shown in FIGS. 9 and 11, the cap isprevented from being opened such that the pen needle 521 cannot bereused. Additionally, by locking the hub 511 within the outer cover 501both ends of the used needle 502 are covered, thereby preventing a userfrom being accidentally stuck by the needle.

Because the tab 505 is locked to the cap 503 by the user, the pen needle521 may be reused as often as desired, which is suitable for personaluse, or used only once, which is suitable for hospital or professionaluse, before locking the tab to the cap. In a professional setting, suchas in a hospital, locking the tab 505 to the cap 503 prevents reuse ofthe pen needle 521, thereby preventing blood cross-contamination betweenpatients. Furthermore, when the tab 505 is locked to the cap 503, thenon-patient end of the needle 502 is also covered, thereby preventingaccidental needle sticks.

In another exemplary embodiment of the present invention, as shown inFIGS. 12-17, a hub and needle of a pen needle 621 are lockable within anouter cover 601.

The outer cover 601, as shown in FIG. 12, has a first undercut 603formed in an inner surface 602 and is adapted to receive the hub 625.The first undercut 603 forms a first flexible member 604 that preventsremoval of the inserted hub 625. Preferably, the first flexible member604 extends entirely around the circumference of the inner surface 602.The outer cover 601 also has a second undercut 605 formed in the innersurface 602 and is adapted to secure an inner shield 611 within theouter cover. The second undercut forms a second flexible member 606 thatprevents removal of the inserted inner shield 611. Preferably, thesecond flexible 606 member extends entirely around the circumference ofthe inner surface 602. The second flexible member 606 engages an outersurface 614 of the projection 615 of the inner shield 611, therebyfacilitating reception of the inner shield as shown in FIG. 15. Theouter cover 601 is preferably clear and is preferably made ofpolypropylene.

The inner shield 611, as shown in FIG. 13, has a base 613 and aprojection 615 extending from the base adapted to cover a needle 623, asshown in FIG. 15. The base 613 of the inner shield 611 has a larger andthicker base that reduces the likelihood of an accidental needle stickwhen a user attempts to dispose the inner shield over the needle 623onto the hub 625. The projection 615 of the inner shield 611 is adaptedto be received by the second undercut 605 of the outer cover 601.

The hub 625 of the pen needle 621, as shown in FIG. 14, has a chamferedflange 627 adapted to be received by the first undercut 603 in the outercover 601, as shown in FIG. 16. The hub 625 is preferably made ofpolypropylene.

FIG. 15 shows the pen needle 621 and inner shield 611 disposed withinthe outer cover 601 before use. The thickness of the base 613 of theinner shield 611 prevents the chamfered flange 627 of the hub 625 frombeing received beyond the first flexible member 604 formed by the firstundercut 603 of the outer cover 601. After the needle 623 of the penneedle 621 is used to administer medication and the hub 625 is stillconnected to the lower housing 17 of the drug delivery device 100 (FIGS.1 and 2), the outer cover 601 is disposed over the hub 625 and needle623 of the pen needle 621, as shown in FIG. 16. Because the inner shield611 is not disposed on the hub 625 of the pen needle 621, the chamferedflange 627 of the hub 625 is now received by first flexible member 604formed by the first undercut 603 of the outer cover 601, as shown inFIG. 16. The chamfered flange 627 flexes the first flexible member 604inwardly, thereby allowing the chamfered flange to move past the firstflexible member. The chamfered flange 627 sits on the first flexiblemember 604, which is prevented from flexing downwardly. Thus, thechamfered flange 627 is locked within the outer cover 601 by the firstflexible member 604, and the pen needle 621 may be removed from thelower housing 17 of the drug delivery device 100.

In a preferred embodiment of the present invention, the glue well 629 ofthe hub 625 of the pen needle 621 is molded or painted a predeterminedcolor, such as red, to indicate that the pen needle has been used, asshown in FIG. 17. As shown in FIG. 15, the opaque inner shield 611covers the glue well of the hub 625 such that the glue well is notvisible to a user when the inner shield is disposed on the hub 625 tocover the needle 623. After the pen needle 621 has been used and thechamfered flange 627 is received by the first flexible member 604 formedby the first undercut 603 in the outer cover 601, the glue well 629 isvisible through the clear cover 601 because it is no longer beingcovered by the inner shield 611, as shown in FIG. 17. The visibility ofthe colored glue well 629 indicates that the needle 623 of the penneedle 621 has been used. Accordingly, if the used pen needle isaccidentally picked up by another user, the visibility of the coloredglue well 629 through the outer cover 601 indicates that the needle 623of the pen needle 621 has been used and should be properly discarded.

The outer cover 601 may have the cap and locking tab of the exemplaryembodiment shown in FIGS. 4-11 to cover the non-patient end of theneedle 623 that is exposed when the hub 625 is locked to the outer cover601. Alternatively, an inner shield 701 may have threads 705 (FIG. 18)or 706 (FIG. 19) on a base 703 that threadably engage threads (by way ofexample, see FIG. 23) on an inner surface 724 of the hub 725, as shownin FIG. 20. Thus, when the hub 725 is locked to the outer cover 711, theouter cover 711 covers the patient end 733 of the needle 731 and theinner shield 701 is connected to the hub 725 to cover the non-patientend 734 of the needle 731.

A projection 704 extends outwardly from the base 703 of the inner shield711. An opening is disposed in the base 703 and a passageway is disposedin the projection 704 to facilitate receiving the needle 731. Theprojection 704 of the inner shield 701 has a closed end 702 to cover thenon-patient end 734 of the needle 731.

In another exemplary embodiment as shown in FIGS. 21-23, an inner shield811 has a stepped base 813. The stepped base has a first portion 815 anda second portion 817, such that the second portion 817 has a smallerouter diameter than the first portion 815, as shown in FIG. 21. Aprojection 812 extends upwardly from the base 813 and has a closed end814 to cover a non-patient end 835 of a needle 831. An opening isdisposed in the base 813 and a passageway is disposed in the projection812 to receive the needle 831, as shown in FIG. 23.

A hub 825, as shown in FIG. 22, has a pair of inwardly extendingflexible arms 827. Preferably, the flexible arms 827 are diametricallyopposed. The needle 831 is rigidly received by the hub 825, as shown inFIG. 23. Threads 826 allow the hub 825 to be threadably connected to alower housing 17 of a drug delivery device 100.

The inner shield 811 is inserted in the hub 825, as shown in FIG. 23, tocover the non-patient end 835 of the needle 831. The first portion 815of the stepped base 813 of the inner shield 811 flexes the arms 827 ofthe hub 825 outwardly as the inner shield is inserted in the hub. Whenthe first portion 815 of the stepped base 813 passes the arms 827, thearms 827 flex back to their initial position and engage the shoulder 819formed between the first and second portions of the base. The largerouter diameter of the first portion 815 of the stepped base 813 preventsthe inner shield 811 from being withdrawn from the hub 825. Thus, theouter cover 801 protects the patient end 833 of the needle 831 and theinner shield 811 protects the non-patient end 835 of the needle 831. Auser may manually flex the arms 827 outwardly to withdraw the innershield 811 from the hub 825.

The foregoing embodiments and advantages are merely exemplary and arenot to be construed as limiting the scope of the present invention. Thedescription of exemplary embodiments of the present invention isintended to be illustrative, and not to limit the scope of the presentinvention. Various modifications, alternatives and variations will beapparent to those of ordinary skill in the art, and are intended to fallwithin the scope of the invention as defined in the appended claims andtheir equivalents.

1. A needle assembly, comprising: a hub; a needle fixedly connected tosaid hub; an outer cover for removably receiving said hub and saidneedle, said outer cover covering a first end of said needle; and aninner shield adapted to be connected to said hub for covering a secondend of said hub.
 2. The needle assembly according to claim 1, whereinsaid inner shield is threadably connected to said hub.
 3. The needleassembly according to claim 1, wherein flexible arms connected to saidhub prevent removal of said inner shield from said hub.
 4. The needleassembly according to claim 3, wherein said inner shield has a steppedbase for engaging said flexible arms.
 5. The needle assembly accordingto claim 4, wherein a user manually flexes the flexible arms outwardlyto disengage the inner shield from the hub.
 6. The needle assemblyaccording to claim 1, wherein the outer cover covers the patient end ofthe needle; and the inner shield covers the non-patient end of theneedle.
 7. A method of preventing reuse of a needle of a needle assemblyfor use with a drug delivery device, comprising the steps of: insertinga used needle assembly in an outer cover to cover at least a first endof said needle assembly; and locking the needle assembly in the outercover to prevent reuse.
 8. The method of preventing reuse according toclaim 7, further comprising covering a second end of said needleassembly.
 9. The method of preventing reuse according to claim 7,further comprising connecting a hub of the needle assembly to the outercover.
 10. The method of preventing reuse according to claim 7, furthercomprising moving a tab of a cap into a recess of the cap to prevent thecap from being removed from the outer cover.
 11. A needle assembly,comprising: a hub; a needle fixedly connected to said hub; an outercover for removably receiving said hub and said needle; a cap movablyconnected to said outer cover; and a tab connected to said outer coverand movable between a first position and a second position, said capbeing movable with respect to said outer cover by said tab in said firstposition and said tab being disposed in said cap in said second positionto prevent a user from moving said cap.
 12. The needle assemblyaccording to claim 11, wherein a living hinge connects said cap to saidouter cover.
 13. The needle assembly according to claim 11, wherein saidcap fits within said outer cover.
 14. The needle assembly according toclaim 11, wherein said cap has a recess for receiving said tab in saidsecond position.